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Home > "B" Clinical Trials Conditions > Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer



Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

For Condition: Lymphoma,Multiple Myeloma,Leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: I. Determine the toxicity of unmanipulated bone marrow augmented with CD34+ enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation. II. Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment, infection, severity of graft-vs-host disease, relapse rate, and cost effectiveness in this patient population. PROTOCOL OUTLINE: Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim (G-CSF)-mobilized, CD34+ enriched peripheral blood stem cells on day 0. Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65. Patients also receive G-CSF subcutaneously daily until blood counts recover. Patients are followed weekly for 3 months, at 6 months and 1 year, and then annually for 5 years. PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 10 Years/65 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosed hematologic malignancy that is eligible for an active allogeneic bone marrow transplantation protocol and leukemia, lymphoma, myeloma, and aplastic anemia treatment protocols - HLA-identical or one antigen-mismatched related donor --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: 10 to 65 - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Other: No known sensitivity to E. coli derivatives
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RichardBurt,  Study Chair,  Robert H. Lurie Cancer Center

Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago,  Illinois,  60611-3013
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067474;  NU-96H4,NCI-G99-1660
Study Start Date: October 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004232

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